MENTOR CPX 4 Breast Tissue Expander 3548212Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317006534), received between May 21, 2018 and Mar 5, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

4 other recalls cover devices cleared under the same FDA submission (K130813); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24523877 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22669047 ↗
• InjuryAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS 350CC TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17443991 ↗
• InjuryAug 8, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT OBSERVED HER RIGHT BREAST EXPANDER WAS DEFLATED. ADDITIONALLY, SHE SUFFERED FROM A PULMONARY EMBOLISM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. PER THE INSTRUCTIONS FOR USE, MENTOR TISSUE EXPANDERS ARE INTENDED FOR TEMPORARY IMPLANTATION UP TO SIX MONTHS, THUS THIS DEVICE IS USED IN A MANNER INCONSISTENT WITH THE IFU AS THE DEVICES HAVE BEEN IMPLANTED FOR APPROXIMATELY 10 MONTHS. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement; Embolism/Embolus

  MAUDE report 15187562 ↗
• MalfunctionAug 2, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER BEING USED IN A RECONSTRUCTIVE BREAST SURGERY WAS FOUND TO BE DEFLATED PRIOR TO OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263763 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 350 CC AND EXPERIENCED INFECTION AND SEROMA (SIDE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available; Seroma; Unspecified Infection

  MAUDE report 8781272 ↗
• MalfunctionAug 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 350CC SALINE BREAST IMPLANTS THAT INTRAOPERATIVELY WHEN SURGEON TRIED TO FILL WITH SALINE IT LEAKED. HE REMOVED THE TISSUE EXPANDER AND TESTED IT OUTSIDE THE PATIENT AND CONFIRMED IT WAS LEAKING. THEY OPENED ANOTHER TISSUE EXPANDER AND INSERTED IT AND FILLED IT WITH SALINE AND EVERYTHING WENT WELL. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7811068 ↗
• InjuryJul 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 350CC IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS DIAGNOSED DURING THE PHYSICAL EXAMINATION. AS A RESULT, PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7709830 ↗
• InjuryMay 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 350 CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST TISSUE EXPANDER. ON (B)(6) 2018, THE SURGEON NOTICED ASYMMETRY DURING INFLATION PROCESS DURING THE EXPANSION PROCESS. THEN, EVERY WEEK ON EXPANSION, THE LEFT TISSUE EXPANDER APPEARED SMALLER IN SIZE. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7530325 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130813. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2026 · Feb 18, 2026 · Open, Classified
  CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
• Z-2781-2016 · Aug 9, 2016 · Terminated
  CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision
• Z-2747-2016 · Aug 9, 2016 · Terminated
  MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy
• Z-2748-2016 · Aug 9, 2016 · Terminated
  MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy